Multiomics Tumor Evolution Model of NSCLC

April 23, 2022 updated by: Jun Wang, Peking University People's Hospital

A Multiomics Study of Tumor Evolution Characteristics and Prognostic Model in Early-stage Non-small Cell Lung Cancer

The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the eligibility criteria will be included consecutively.

Description

Inclusion Criteria:

  1. Age ≥ 18 years old;
  2. Early-stage NSCLC patients underwent radical surgical resection;
  3. Sufficient tumor tissue and blood sample for study use;
  4. Available clinical-pathologic data, imaging data and follow-up date;
  5. Written informed consent.

Exclusion Criteria:

  1. History of other malignant tumors;
  2. Evidence of distant metastasis before surgery;
  3. Insufficient tumor tissue or blood sample for study use;
  4. Clinical-pathologic data, imaging data or follow-up date is not available;
  5. Other judgments by the Investigator that the patient should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prospective cohort
This cohort will enroll a total of 300 patients prospectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: Through study completion, an average of 2 years
Time from randomization to disease recurrence or death from any cause.
Through study completion, an average of 2 years
Overall survival (OS)
Time Frame: Through study completion, an average of 2 years
Time from randomization to death from any cause.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between translational biomarkers and clinical outcome
Time Frame: Through study completion, an average of 2 years
To evaluate if the translational biomarkers can be prediction tools for the clinical outcomes.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Research Unit of Intelligence Diagnosis and treatment of early-stage non-small cell lung cancer, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Jun Wang, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 23, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 23, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-I2M-5-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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